Job Title

Quality Assurance Manager

Location

Culver City, CA

Job Description

The Quality Assurance Manager oversees daily QA/QC activities, ensure raw material, component, in-process and finished products are released properly. Supervise QA/QC staff. Perform and manage non-conforming materials and products. Evaluate and validate production processes including: compounding, manufacturing, filling and packing, water system, cleaning and sanitization. Essential Job Functions -- Duties and Responsibilities 1. Implement and manage product safety and quality programs in order to comply with FDA regulations inclusive of 21CFR parts 210 and 211 and EU cosmetics regulations. 2. Monitor and supervise the activities of laboratory where technicians perform physical, chemical and microbiological tests of incoming ingredients, bulk, packaging, and finished goods. 3. Initiate and investigate any non-conforming materials or products. Issue and manage corrective action to prevent reoccurrence. 4. Review and establish testing requirements for each product, manage testing by outside testing laboratories, and validate testing methods. Inclusive of evaluating new raw materials, components, and finished products. 5. Implement programs and standards to adhere to ISO 9001-2000 requirements, manage recertification and audit requirements for ISO standard. 6. Promote product safety and quality by providing support and training to Operations, Quality and Sanitation functions. 7. Develop, train, and lead QA/QC staff consistent with the leadership values and maximize their potential through performance assessment and development. 8. Manage chemical waste disposal. 9. Assume responsibility for batch releases by being able to adjust in-process batches and manage out-of-spec batches. Approval of master documents and documentation of quality investigations 10. Implement and manage internal verification and validation programs according to cGMP, FDA regulatory requirements and ISO standard. 11. Manage OTC stability on finished goods. 12. Manage review of production records to ensure appropriate specifications are met and all products released are compliant with specifications. Inclusive of but not limited to: o Daily component and raw material receiving reports o Batch records for in-process materials and finished products o Component and raw material receiving o Master Formulas o Raw material and finished product retain samples Supervisory Responsibilities 1. Direct supervision of Quality Supervisor and Microbiologist. 2. Accountability for hiring, firing and performance evaluations for all direct reports.

Qualifications

Qualifications 1. Bachelor's degree in Operations, Technical Management, Science discipline or equivalent experience preferred. 2. Minimum of 5 years supervisory experience in a personal care manufacturing consumer goods environment. OTC products preferred. 3. Two years of Continuous Improvement, Total Quality, Team Based Management experience or equivalent preferred. 4. Knowledge of cGMP in manufacturing, processing, packing, or holding of drugs 5. Knowledge of cGMP for finished pharmaceuticals manufacturing, including but not limited to management of: batch records, specifications, inspection and release procedures according to MIL 105 or ANIS Z1.4 sampling plans and prerequisite programs. 6. Knowledge of chemical waste management 7. Excellent communication skills (verbal and written). 8. Willingness to actively participate in leadership management training and support activities. 9. Self starter with ability to work independently, meet deadlines, multi-task with a positive can-do attitude. 10. Outgoing, solution-oriented people-centered management style. 11. Ability to problem solve and make timely decisions. 12. Computer skills (Microsoft Access, Word, Excel, PowerPoint, Email). 13. Ability to meet attendance requirements. 14. Ability to maintain an effective working relationship with all contacts both inside and outside the company.